Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)

Part of paid clinical trials in Corona, California.

Sponsor
MicuRx
Study ID
NCT05369052
Phase
PHASE3
Status
Recruiting
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Conditions

  • Diabetic Foot Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • contezolid acefosamil (IV)/contezolid (PO) — DRUG
    Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)
  • Linezolid (IV and PO) — DRUG
    Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)

Study Details

This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.

Key Dates

Start date
May 3, 2022
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
865 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: contezolid acefosamil/contezolid
  • Active Comparator: linezolid

Primary Outcome Measure

Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators [ Time Frame: Day 35 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
New Hope Research DevelopmentCoronaCalifornia92882-
ILD Research CenterVistaCalifornia92081-

Find similar trials in Corona, CA

By research site
New Hope Research Development· Corona, CAILD Research Center· Vista, CA

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